Airway DiseaseCuirassNCT06136858
Cuirass Fitting Study - Time for Mounting and Ventilation
An observational study of Airway Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Non-invasive biphasic cuirass ventilation (BCV) has recently been described for ENT surgery (ref 1-2). The clinical experience is however still sparse and further study is required. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Airway Disease
- What is being tested?
- Cuirass ventilation
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Nov 2023to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: The study population is healthy volunteers, mostly doctors, who participate in a large airway management course i Copenhagen.
Who may be able to join
- participants of the airway course
Who cannot join
- Recent surgery in thoracic or abdominal compartments
- participants with pace-maker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cuirass Shell Fitting and Time to Visible Ventilation in Healthy Volunteers - an Observational Study.
Non-invasive biphasic cuirass ventilation (BCV) has recently been described for ENT surgery (ref 1-2). The clinical experience is however still sparse and further study is required.
The purpose of the study is to descibe 1) mounting time and fitting of the cuirass shell on voluntary participants and 2) time to visible ventilation
Read the detailed description
The purpose of this study is to evaluate the the fitting of the Cuirass shell on healthy volunteers. Even though there is growing knowledge of Cuirass ventilation in anaesthesia, (ref. 1-2) there is sparse experiences with the time required for fitting the Cuirass shell and the time to start of ventilation. This knowledge is paramount before even discussing the potential use of Cuirass ventilation in acute settings in the future.
In addition to the invitation to the Copenhagen Airway Management course in Copenhagen Denmark on 30th of November 2023, all participants have been invited an has accepted to participate in the study.
In total 60 to 65 participants will all have the Cuirass shell fitted and will be awake ventilated with Biphasic Cuirass Ventilation. All participants have given consent to being video filmed.
The study will register the time it takes to fit the Cuirass shell and the time before visible ventilation is obtained.
All participants will be in their habitual state i.e..no sedation is required since the product was originally designed for home use in awake patients.
- Conditions
- Airway Disease
- Being tested
- Cuirass ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cuirass ventilationDevice
We will fit the Cuirass Shell and start Biphasic Cuirass Ventilation on all participants.
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | participants of the Airway management Course in Copenhagen Denmark 2023 Receives: Device: Cuirass ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point of the study is to evaluate the number of participants who are fitted with the Cuirass shell and have visible ventilation in a two liters breathing bag within three minutes.
Timing of the above
Measured: 15 minuttes
Secondary outcomes (1)
Mean time for fitting of the cuirass shell and start of visible ventilation and fraction of participants who can be ventilated within one minute and within two minuttes
timing of the above
Measured: 15 minuttes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start30 Nov 2023 (estimated)
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Airway DiseaseStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jakob Friis Schmidt, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136858
- Sponsor's protocol ID
- The Cuirass Fitting Trial
- Acronym
- Cuirass
- Status last verified
- Nov 2023
- First submitted
- 6 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kristensen MS, Hesselfeldt R, Schmidt JF. Improvements in cuirass ventilation for airway surgery: origins in Copenhagen on the 70th anniversary of the first intensive care unit. Br J Anaesth. 2023 Oct;131(4):644-648. doi: 10.1016/j.bja.2023.07.021. Epub 2023 Sep 4.
PubMed 37718095Kristensen MS, Hesselfeldt R, Schmidt JF. Modern cuirass ventilation for airway surgery: unlimited access to the larynx and trachea in anaesthetised patients. Br J Anaesth. 2023 Oct;131(4):e106-e109. doi: 10.1016/j.bja.2023.07.010. Epub 2023 Aug 14. No abstract available.
PubMed 37587006
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cuirass Shell Fitting and Time to Visible Ventilation in Healthy Volunteers - an Observational Study.
- ClinicalTrials.gov ID
- NCT06136858
- Acronym / sponsor ID
- Cuirass / The Cuirass Fitting Trial
- Conditions
- Airway Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 30 Nov 2023 (estimated)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-invasive biphasic cuirass ventilation (BCV) has recently been described for ENT surgery (ref 1-2). The clinical experience is however still sparse and further study is required.
The purpose of the study is to descibe 1) mounting time and fitting of the cuirass shell on voluntary participants and 2) time to visible ventilation
Detailed description
The purpose of this study is to evaluate the the fitting of the Cuirass shell on healthy volunteers. Even though there is growing knowledge of Cuirass ventilation in anaesthesia, (ref. 1-2) there is sparse experiences with the time required for fitting the Cuirass shell and the time to start of ventilation. This knowledge is paramount before even discussing the potential use of Cuirass ventilation in acute settings in the future.
In addition to the invitation to the Copenhagen Airway Management course in Copenhagen Denmark on 30th of November 2023, all participants have been invited an has accepted to participate in the study.
In total 60 to 65 participants will all have the Cuirass shell fitted and will be awake ventilated with Biphasic Cuirass Ventilation. All participants have given consent to being video filmed.
The study will register the time it takes to fit the Cuirass shell and the time before visible ventilation is obtained.
All participants will be in their habitual state i.e..no sedation is required since the product was originally designed for home use in awake patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | – | Device: Cuirass ventilationparticipants of the Airway management Course in Copenhagen Denmark 2023 |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study population is healthy volunteers, mostly doctors, who participate in a large airway management course i Copenhagen.
Key inclusion criteria (1 listed)
- participants of the airway course
Key exclusion criteria (2 listed)
- Recent surgery in thoracic or abdominal compartments
- participants with pace-maker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cuirass ventilationWe will fit the Cuirass Shell and start Biphasic Cuirass Ventilation on all participants. | Device | healthy volunteers |
Primary outcome
The primary end point of the study is to evaluate the number of participants who are fitted with the Cuirass shell and have visible ventilation in a two liters breathing bag within three minutes.
Time frame: 15 minuttes
Timing of the above
1 secondary outcome
Mean time for fitting of the cuirass shell and start of visible ventilation and fraction of participants who can be ventilated within one minute and within two minuttes
Time frame: 15 minuttes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 37718095Kristensen MS, Hesselfeldt R, Schmidt JF. Improvements in cuirass ventilation for airway surgery: origins in Copenhagen on the 70th anniversary of the first intensive care unit. Br J Anaesth. 2023 Oct;131(4):644-648. doi: 10.1016/j.bja.2023.07.021. Epub 2023 Sep 4.
- Background: PubMed 37587006Kristensen MS, Hesselfeldt R, Schmidt JF. Modern cuirass ventilation for airway surgery: unlimited access to the larynx and trachea in anaesthetised patients. Br J Anaesth. 2023 Oct;131(4):e106-e109. doi: 10.1016/j.bja.2023.07.010. Epub 2023 Aug 14. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary end point of the study is to evaluate the number of participants who are fitted with the Cuirass shell and have visible ventilation in a two liters breathing bag within three minutes. (time frame: 15 minuttes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06136858, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.